Natural Res. Def. Council, Inc. v. U.S. Food & Drug Admin.

• Decision Date: 12 April 2022
• Docket Number: 19-CV-10005 (VSB)
• Citation: 598 F.Supp.3d 98
• Parties: NATURAL RESOURCES DEFENSE COUNCIL, INC., Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Environmental Defense Fund, and Environmental Working Group, Plaintiffs, v. U.S. FOOD AND DRUG ADMINISTRATION, and Robert M. Califf, M.D., in his official capacity as Commissioner of the Food and Drug Administration, Defendants.
• Court: U.S. District Court — Southern District of New York

598 F.Supp.3d 98

NATURAL RESOURCES DEFENSE COUNCIL, INC., Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Environmental Defense Fund, and Environmental Working Group, Plaintiffs,

v.U.S. FOOD AND DRUG ADMINISTRATION, and Robert M. Califf, M.D., in his official capacity as Commissioner of the Food and Drug Administration, Defendants.

19-CV-10005 (VSB)

United States District Court, S.D. New York.

Signed April 12, 2022

Sarah Valentine Fort, Natural Resources Defense Council, Washington, D.C., Counsel for Plaintiff Natural Resources Defense Council, Inc.

Alexis Charlotte Andiman, Carrie Apfel, Earthjustice, New York, New York, Counsel for Plaintiffs Breast Cancer Prevention Partners, Center for Environmental Health, Environmental Defense Fund, and Environmental Working Group.

Peter Max Aronoff, Zachary Bannon, United States Attorney's Office for the Southern District of New York, New York, New York, Shannon L. Pederson, United States Department of Justice Consumer Protection Branch, Washington, D.C., Counsel for Defendants U.S. Food and Drug Administration and Norman E. Sharpless in his official capacity as Acting Commissioner of the Food and Drug Administration.

OPINION & ORDER

VERNON S. BRODERICK, United States District Judge:

Plaintiffs Natural Resources Defense Council, Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Environmental Defense Fund, and Environmental Working Group (together, "Plaintiffs") seek declaratory and injunctive relief against Defendants United States Food and Drug Administration ("FDA") and Robert M. Califf, M.D. ("Califf") in his official capacity as Commissioner of the Food and Drug Administration¹ (together, "FDA"). Specifically, Plaintiffs seek declaratory and injunctive relief with respect to the FDA's denial of Plaintiffs’ citizen petition regarding a Threshold of Regulation ("TOR") exemption that allowed the inclusion of the chemical compound sodium perchlorate monohydrate in plastic food-contact articles. Currently before me are Plaintiffs’ motion for summary judgment on the grounds that the FDA's denial of its citizen petition violated the Administrative Procedure Act ("APA") and the Food Safety Act ("the Food Act"), and the FDA's cross-motion for summary judgment arguing that the decision did not violate either act and that its agency expert judgments are entitled to deference. Because I find the FDA's decision denying Plaintiffs’ citizen petition was neither arbitrary nor capricious in violation of the APA and did not violate the Food Act, the FDA's motion for summary judgment is GRANTED and Plaintiffs’ motion is DENIED.

I. Factual Background ²

Sodium perchlorate monohydrate ("perchlorate") is a chemical compound used as an additive in plastic packaging and other food-contact articles³ to reduce the buildup of static charges resulting from the movement of dry foods, like cereal, flour, and spices. (Compl. ¶ 2; FDA 1821.) If the accumulated static charge reaches a high enough level, it can produce a spark that can ignite the dust and powder created in dry foods and cause a dust explosion. (Compl. ¶ 53; FDA 2473.) The purpose of an antistatic agent such as perchlorate is to dissipate the charge that accumulates from the flowing dry food. (Compl. ¶ 54; FDA 1487–88, 3145.) Historically, perchlorate has also been used in rocket fuel, ammunition, fireworks, and explosives. (Compl. ¶ 58; FDA 1936.) Once ingested, perchlorates can disrupt the human endocrine system and can affect normal growth and development in fetuses, infants, and children. (FDA 1886, 1948, 2191, 2195–202.)

A. Regulatory and Statutory Background

The Food Act prohibits the introduction of any "adulterated" food into interstate commerce. 21 U.S.C. § 331(a). A food is "adulterated" if it contains an "unsafe" "food additive." Id. § 342(a)(2)(C)(i). A "food additive" includes "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food[).]" Id. § 321(s); see also id. § 348(h)(6) (defining the subset of food additives known as "food contact substance[s]"). A "food additive" is "deemed unsafe," and thus food containing the additive is "adulterated," id. § 342(a)(2)(C), unless a "regulation issued under this section prescribing the conditions under which such additive may be safely used" is "in effect," and "such substance and the use of such substance are in conformity with" that regulation, id. § 348(a)(3). The Food Act requires that the FDA, "[i]n determining ... whether a proposed use of a food additive is safe," consider "the cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substance or substances in such diet." Id. § 348(c)(5)(B).

The FDA has also developed the TOR procedures for any food additive that migrates from a food-contact article to food itself at such low concentrations as to be "below the threshold of regulation." 21 C.F.R. § 170.39(a). Under this procedure, such food additives are not subject to the requirement under 21 U.S.C. § 348 that a food-additive regulation be in effect. (Compl. ¶ 39.) To qualify for a TOR exemption, the "use in question" must be "shown to result in" or "be expected to result in.... dietary concentrations at or below 0.5 parts per billion," ("ppb"), which the FDA calculates as "corresponding to dietary exposure levels at or below 1.5 micrograms/person/day (based on a diet of 1,500 grams of solid food and 1,500 grams of liquid food per person per day)." 21 C.F.R. § 170.39(a)(2)(i). Once a TOR exemption is in place, any manufacturer may use the substance in accordance with the exemption, and use of a substance in accordance with a TOR exemption is not limited to use by the entity that requested the exemption. Id. § 170.39(g). The FDA did not receive any public comments advocating for lower thresholds or expressing safety concerns with the agency's TOR exemption proposal. (FDA 1368–69.)

On June 17, 2005, Ciba Specialty Chemicals Corporation ("Ciba") submitted a request for a TOR exemption allowing for the use of sodium perchlorate monohydrate in a packaging material to be known as Irgastat P18. (Compl. ¶¶ 68–69; FDA 3124–47.) The FDA issued TOR Exemption No. 2005-006 ("TOR Exemption"), (Compl. ¶¶ 68–69; FDA 3153–54), which authorizes the use of perchlorate as a conductivity enhancer in antistatic agents, at a maximum concentration of 4% in the antistatic agent and 1.2% by weight in the finished article, for use in contact with dry foods, (Compl. ¶ 70; FDA 3153–54).

B. The FDA Studies

Since 1961, and on an ongoing basis, the FDA has conducted the Total Diet Study, which is intended to monitor the U.S. food supply for, among other things, chemical contaminants. (Compl. ¶ 72.) In 2008, FDA scientists published a peer-reviewed study estimating dietary intake of perchlorate and iodine from its Total Diet Study samples collected in 2005 and 2006 ("2008 Study"). (Id. ¶ 76; FDA 1633–42 (Murray et al., US Food and Drug Administration's Total Diet Study: Dietary intake of perchlorate and iodine at 572 (2008)).) The 2008 study reported detectable levels of perchlorates in 59% of all samples analyzed, including detectable levels in at least one sample of 74% of all foods. (FDA 1637.)

On December 21, 2016, FDA scientists updated the 2008 study with a published, peer-reviewed analysis of the Total Diet Study samples collected from 2008 to 2012 ("2016 Study"). (Compl. ¶ 77.) On May 3, 2017, the FDA published a summary of the 2016 Study, including more detailed data, on its website ("2017 Report"). (Id. ¶ 78.) That study showed that samples of those same types of foods collected in the years following the FDA's approval of the TOR Exemption had higher levels of perchlorate contamination. (See Abt et al., Update on dietary intake of perchlorate and iodine from U.S. food and drug administration's total diet study: 2008-2012, 28 J. Exposure Sci. & Enviro. Epidemiology 21 (2018) (published online Dec. 14, 2019).)

C. Plaintiffs’ Petition

Any "interested person may petition the [FDA] Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action." 21 C.F.R. § 10.25(a). Such petition may take "the form for a citizen petition in [ 21 C.F.R.] § 10.30." Id. § 10.25(a)(2). A citizen petition is a public document available for comment at www.regulations.gov. Id. § 10.30(b)(1).

In 2014, Plaintiffs, along with a number of other nonprofit organizations, petitioned the FDA to reconsider and revoke the TOR Exemption and to promulgate a rule banning the use of perchlorate in food-contact materials. (Compl. ¶¶ 1, 7; FDA 1674–77.) On May 4, 2017, the FDA denied this petition. (Compl. ¶¶ 1, 8, 85; FDA 1883–2459.) On June 4, 2017, Plaintiffs filed objections to the FDA's denial. (Compl. ¶ 13; FDA 2463–92.) The FDA denied Plaintiffs’ objections in April 2019. (Compl. ¶ 86; FDA 3109–12.) On April 24, 2019, the FDA sent Plaintiffs a letter elaborating on its reasons for the denial, and explaining that any objection that raises new information not included within the original petition could only be considered in connection with a new citizen petition. (FDA 3113–23.)

II. Procedural History

Plaintiffs initiated this action by filing the Complaint on October 29, 2019. (Doc. 1.) Plaintiffs sought relief based upon three assertions: (1) The FDA violated the APA by ignoring data from the Total Diet Study samples and its own analyses of that data, (2) the FDA violated the Food Act and the APA by failing to consider the cumulative effects of perchlorate in the diet, and (3) the FDA violated the APA by failing to account for...